University of Pittsburgh
Carla Mazefsky
Too few clinicians are able and willing to help autistic patients. A recent review identified challenges to mental health service delivery in autism, including a lack of interventions designed for community implementation and limited workforce capacity. It has been argued that improving impairment in emotion regulation has the potential to improve a range of mental health difficulties in autistic people. In this clinical trial, the investigators are comparing two evidence-based interventions for emotion regulation, to determine if one created specifically for autistic people is clinically superior. The interventions will be implemented in the community, through partnering agencies.
Autism Spectrum Disorder
The Emotion Awareness and Skills Enhancement Program
The Unified Protocol
NA
This study will compare the effectiveness of two transdiagnostic interventions for autistic adolescents and young adults - an intervention in widespread use among non-autistic populations (The Unified Protocol; UP) versus an autism-specific intervention (The Emotion Awareness and Skills Enhancement Program; EASE). The UP and EASE are ideal comparators because they are structurally equivalent and transdiagnostic - both shown to improve mental health outcomes that stakeholders identify as important, such as depression, irritability, and anxiety. The investigators will partner with 10 different community clinics in Pennsylvania and Alabama to recruit participants and facilitate the interventions. Each clinic will be randomized to use either UP or EASE. The investigators will look at effectiveness of the treatments, as well as the feasibility, benefits and harms.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 470 participants |
| Masking : | SINGLE |
| Masking Description : | A rater blind to condition assignment will assign CGI ratings. |
| Primary Purpose : | TREATMENT |
| Official Title : | The Emotion Awareness and Skills Enhancement (EASE) Program Versus the Unified Protocol (UP) |
| Actual Study Start Date : | 2024-04-08 |
| Estimated Primary Completion Date : | 2027-08-01 |
| Estimated Study Completion Date : | 2027-08-01 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 12 Years to 25 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: | 1 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
University of Alabama
Tuscaloosa, Albama, United States, 35401
RECRUITING
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213